COLD-EEZE CHILDRENS NIGHTTIME COLD AND COUGH RELIEF- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride liquid

Cold-EEZE by

Drug Labeling and Warnings

Cold-EEZE by is a Otc medication manufactured, distributed, or labeled by ProPhase Labs, Inc., Pharmaloz Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients (in each 10 mL)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Diphenhydramine HCl 12.5mg	Antihistamine/cough suppressant
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

• temporary relief for these common cold and flu symptoms:
  • minor aches and pains
  • headache
  • sore throat
  • nasal congestion
  • runny nose
  • sneezing
  • cough
• controls cough to help your child get to sleep
• temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if your child takes:

• more than 5 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen

Allergy alert

Acetaminophen may cause severe skin reactions.
Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Avoid foods or beverages that contain caffeine.

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• to make a child sleepy
• with any other drug containing diphenhydramine, even one used on the skin
• in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if your child has

• liver disease
• heart disease
• diabetes
• high blood pressure
• thyroid disease
• glaucoma
• a breathing problem such as chronic bronchitis
• persistent or chronic cough such as occurs with asthma
• cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if your child is

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

When using this product

• do not use more than directed
• excitability may occur, especially in children
• marked drowsiness may occur
• sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• pain, nasal congestion, or cough gets worse or lasts more than 5 days
• fever gets worse, or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

Keep out of reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• this product does not contain directions or complete warnings for adult use
• do not give more than directed (see Overdose warning)
• if needed, repeat dose every 4 hours while symptoms last
• do not give more than 5 days unless directed by a doctor
• measure only with dosing cup provided
• do not use dosing cup with other products
• dose as follows or as directed by a doctor
• mL = milliliter
• children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours; do not give more than 5 doses in any 24-hour period
• children under 6 years of age: do not use

Other information

• each 10 mL contains: sodium 6 mg
• store between 20-25°C (68-77°F)
• dosing cup provided
• do not refrigerate
• dosing cup provided
• tamper evident: do not use if foil seal under bottle cap is open or missing

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions?

1-800-505-2653
(M-F: 9AM-5PM EST)
You may also report side effects to this phone number

SPL UNCLASSIFIED SECTION

Manufactured for and
Distributed by:
ProPhase Labs, Inc.
PO Box 1349
Doylestown, PA 18901

PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label

Children's
Cold-EEZE®
Nighttime
Cold & Cough

3001000213--47011

NDC: 61941-0401-1

Acetaminophen 325 mg Pain Reliever/Fever Reducer

Diphenhydramine HCl 12.5 mg Antihistamine/Cough Suppressant

Phenylephrine HCl 5 mg Nasal Decongestant

MULTI-SYMPTOM

Relief of:

• ✓ Cough
• ✓ Sore Throat
• ✓ Fever
• ✓ Stuffy Nose

Alcohol Free

Berry Flavor

For Ages 6+
6 fl oz (180 mL)

INGREDIENTS AND APPEARANCE

COLD-EEZE   CHILDRENS NIGHTTIME COLD AND COUGH RELIEF
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61941-0401
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	325 mg  in 10 mL
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M)	Diphenhydramine Hydrochloride	12.5 mg  in 10 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	5 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
Anhydrous Citric Acid (UNII: XF417D3PSL)
Edetate Disodium (UNII: 7FLD91C86K)
FD&C Blue NO. 1 (UNII: H3R47K3TBD)
FD&C Red NO. 40 (UNII: WZB9127XOA)
Glycerin (UNII: PDC6A3C0OX)
Propylene Glycol (UNII: 6DC9Q167V3)
Propyl Gallate (UNII: 8D4SNN7V92)
Water (UNII: 059QF0KO0R)
Sodium Benzoate (UNII: OJ245FE5EU)
Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)
Sorbitol (UNII: 506T60A25R)
Sucralose (UNII: 96K6UQ3ZD4)
Xanthan Gum (UNII: TTV12P4NEE)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61941-0401-1	180 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	01/01/2016

Labeler - ProPhase Labs, Inc. (620557298)

Establishment
Name	Address	ID/FEI	Business Operations
ProPhase Labs, Inc.		620557298	LABEL(61941-0401) , ANALYSIS(61941-0401) , REPACK(61941-0401)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaloz Manufacturing, Inc.		067101998	MANUFACTURE(61941-0401) , PACK(61941-0401) , REPACK(61941-0401)